BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 3864605 · Received June 10, 2014

    Report

    Report Number
    2032227-2014-03038
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    April 28, 2014
    Report Date
    June 2, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH ALARM DURING BASIC OCCLUSION TEST DUE TO PROTRUDED/LOOSE DRIVE SUPPORT DISK. IT WAS UNABLE TO PERFORM THE OCCLUSION, PRIME AND EXCESSIVE NO DELIVERY TESTS DUE TO ALARMS. UNIT RECEIVED WITH CRACKED RESERVOIR TUBE LIP, SCRATCHED RESERVOIR TUBE WINDOW AND MISSING END CAP STICKER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER'S INSULIN PUMP WAS ALARMING DURING REWIND PRIME PROCESS. CALLER STATED THAT THE CUSTOMER HAD HIGH BLOOD GLUCOSE AND TREATED WITH MANUAL INJECTION. CALLER ALSO STATED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO DOUBLE PNEUMONIA. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339176 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-715LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization